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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION PROPONENT EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L221
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Erosion (1750); Unspecified Infection (1930)
Date of Event 05/18/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
It was reported that this product was part of a system revision due to infection and erosion.There were no additional adverse effects reported.
 
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Brand Name
PROPONENT EL DR
Common Device Name
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key10233894
Report Number2124215-2020-11195
Device Sequence Number14238737
Product Code LWP
UDI-Device Identifier00802526559112
UDI-Public00802526559112
Combination Product (Y/N)N
Initial Reporter CountryTD
PMA/510(K) Number
N970003/S167
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date12/16/2021
Device Model NumberL221
Device Catalogue NumberL221
Device Lot Number728906
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/18/2020
Initial Report FDA Received Date07/06/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other; Required Intervention;
Patient Age72 YR
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